Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families

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Wolf S. M. , “Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 440–463.

Fernandez C. V. , “Attitudes of Researchers to the Return to Participants of Incidental and Targeted Genomic Findings Obtained in a Research Setting,” Genetics in Medicine 15, no. 7 (2013): 558–564; Kozanczyn C. Collins K. Fernandez C. V. , “Offering Results to Research Subjects: U.S. Institutional Review Board Policy,” Accountability in Research 14, no. 4 (2007): 255–267; Simon C. M. , “Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives,” Journal of Empirical Research on Human Research Ethics 6, no. 4 (2011): 53–67; Williams J. K. , “Researcher and Institutional Review Board Chair Perspectives on Incidental Findings in Genomic Research,” Genetic Testing and Molecular Biomarkers 16, no. 6 (2012): 508–513; Zawati M. H. , “Reporting Results from Whole-Genome and Whole-Exome Sequencing in Clinical Practice: A Proposal for Canada?” Journal of Medical Genetics 51, no. 1 (2013): 68–70; Mac-Neil S. D. Fernandez C. V. , “Informing Research Participants of Research Results: Analysis of Canadian University Based Research Ethics Board Policies,” Journal of Medical Ethics 32, no. 1 (2006): 49–54; Keane M. A. , “Institutional Review Board Approaches to the Incidental Findings Problem,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 352–355.

Fernandez C. V. , “Attitudes of Canadian Researchers Toward the Return to Participants of Incidental and Targeted Genomic Findings Obtained in a Pediatric Research Setting,” Genetics in Medicine 15, no. 7 (2013): 558–564; Henderson G. E. , “What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011,” Journal of Law, Medicine & Ethics 40, no. 4 (2012): 1008–1024; Downing N. R. , “Genetics Specialists' Perspectives on Disclosure of Genomic Incidental Findings in the Clinical Setting,” Patient Education and Counselling 90, no. 1 (2013): 133–138.

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010), available at <http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf> (last visited August 12, 2015) [hereinafter Tri-Council Policy Statement]; Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005), available at <http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm> (last visited August 12, 2015); National Institutes of Health (NIH), NCI Best Practices for Biospecimen Resources (2011), available at <http://biospecimens.cancer.gov/practices/2011bp.asp> (last visited August 12, 2015).

Council of Europe, supra note 8; Beier K. , “The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe – Proceedings of the Tiss.EU Project (2011),” available at <http://www.oapen.org/search?identifier=407336> (last visited August 12, 2015).

Beskow L. M. O'Rourke P. P. , “Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 502–513.

Fluid Surveys Ultra Version, available at <http://fluidsurveys.com/> (last visited August 12, 2015).

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Fernandez C. V. , “Attitudes of Parents toward the Return of Targeted and Incidental Genomic Research Findings in Children,” Genetics in Medicine 16, no. 8 (2014): 633–640; Meulenkamp T. M. , “Communication of Biobanks' Research Results: What Do (Potential) Participants Want?” American Journal of Medical Genetics 152A, no. 10 (2010): 2482–2492; Tabor H. K. , “Genomics Really Gets Personal: How Exome and Whole Genome Sequencing Challenge the Ethical Framework of Human Genetics Research,” American Journal of Medical Genetics 155, no. 12 (2011): 2916–2924; Trinidad S. B. , “Genomic Research and Wide Data Sharing: Views of Prospective Participants,” Genetics in Medicine 12, no. 8 (2010): 486–495.

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Kaufman D. , “Public Opinion About the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 643–654; Jamal L. , “Research Participants' Attitudes towards the Confidentiality of Genomic Sequence Information,” European Journal of Human Genetics 22 (2013): 964–968; Milner L. C. Liu E. Y. Garrison N. A. , “Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects,” American Journal of Bioethics 13, no. 10 (2013): 66–67; American Medical Association Opinion 2.131 – Disclosure of Familial Risk in Genetic Testing (2003), available at <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2131.page?> (last visited August 12, 2015).

See Beskow O'Rourke , supra note 10.

Kohlmeier G. Z. A. , “The Risky Business of Lifestyle Genetic Testing: Protecting against Harmful Disclosure of Genetic Information,” University of California Los Angeles Journal of Law and Technology 11 (2007): 5–57; National Health and Medical Research Council, “Use and Disclosure of Genetic Information without Consent: A Decision-Making Tool for Health Practitioners—Who, When, Why and How?” Internal Medicine Journal 41, no. 8 (2011): 634–638.

Tri-Council Policy Statement, supra note 8.

Hoffman D. E. Fortenberry E. Ravel J. , “Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project,” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 454–469.

Thorogood A. , “An Implementation Framework for the Feedback of Individual Research Results And Incidental Findings in Research,” BMC Medical Ethics 15, no. 1 (2014): 88; Zawati , supra note 6; Henderson G. E. , “The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations,” Journal of Law, Medicine & Ethics 42, no. 3 (2014): 344–355.

Green R. C. , “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574; Jarvik G. P. , “Return of Genomic Results To Research Participants: The Floor, the Ceiling, and the Choices in Between,” American Journal of Human Genetics 94, no. 6 (2014): 818–826; Burke W. , “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11 (2013): 854–859; Ross L. F. Rothstein M. A. Clayton E. , “Mandatory Extended Searches in All Genome Sequencing: ‘Incidental Findings,’ Patient Autonomy, and Shared Decision Making,” JAMA 310, no. 4 (2013): 367–368.